A Study to Evaluate Safety, Reactogenicity, and Immune Response of GVGH iNTS-TCV Vaccine Against Invasive Nontyphoidal Salmonella and Typhoid Fever

Full name

A Phase 1/2a, Observer-blind, Randomized, Controlled, Two-stage, Multi-country Study to Evaluate the Safety, Reactogenicity, and Immune Response of the Trivalent Vaccine Against Invasive Nontyphoidal Salmonella (iNTS) and Typhoid Fever in Healthy European and African Adults

NCT Number

NCT05480800

Geography

Non-US

Locations

Belgium, Malawi

Primary Endpoints

Number of participants in Europe/Stage 1 with solicited administration site events after the first study intervention administration. During 7 days after the first study intervention administration occurring at Day 1
Number of participants in Europe/Stage 1 with solicited administration site events after the second study intervention administration. During 7 days after the second study intervention administration occurring at Day 57
Number of participants in Europe/Stage 1 with solicited administration site events after the third study intervention administration. During 7 days after the third study intervention administration occurring at Day 169
Number of participants in Europe/Stage 1 with solicited systemic events after the first study intervention administration. During 7 days after the first study intervention administration occurring at Day 1
Number of participants in Europe/Stage 1 with solicited systemic events after the second study intervention administration. During 7 days after the second study intervention administration occurring at Day 57
Number of participants in Europe/Stage 1 with solicited systemic events after the third study intervention administration. During 7 days after the third study intervention administration occurring at Day 169
Number of participants in Europe/Stage 1 with unsolicited adverse events (AEs) after the first study intervention administration. During 28 days after the first study intervention administration occurring at Day 1
Number of participants in Europe/Stage 1 with unsolicited adverse events (AEs) after the second study intervention administration. During 28 days after the second study intervention administration occurring at Day 57
Number of participants in Europe/Stage 1 with unsolicited adverse events (AEs) after the third study intervention administration. During 28 days after the third study intervention administration occurring at Day 169
Number of participants in Europe/Stage 1 with serious adverse events (SAEs). From first study intervention administration (Day 1) up to 28 days after the third study intervention administration (Day 197)
Number of participants in Europe/Stage 1 with AEs/SAEs leading to withdrawal from the study and/or withholding doses of study intervention. From first study intervention administration (Day 1) up to 28 days after the third study intervention administration (Day 197)
Number of participants in Europe/Stage 1 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 8
Number of participants in Europe/Stage 1 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 64
Number of participants in Europe/Stage 1 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 176
Number of participants in Europe/Stage 1 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 29
Number of participants in Europe/Stage 1 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 85
Number of participants in Europe/Stage 1 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 197
Number of participants in Africa/Stage 2 with solicited administration site events after the first study intervention administration. During 7 days after the first study intervention administration occurring at Day 1
Number of participants in Africa/Stage 2 with solicited administration site events after the second study intervention administration. During 7 days after the second study intervention administration occurring at Day 57
Number of participants in Africa/Stage 2 with solicited administration site events after the third study intervention administration. During 7 days after the third study intervention administration occurring at Day 169
Number of participants in Africa/Stage 2 with solicited systemic events after the first study intervention administration. During 7 days after the first study intervention administration occurring at Day 1
Number of participants in Africa/Stage 2 with solicited systemic events after the second study intervention administration. During 7 days after the second study intervention administration occurring at Day 57
Number of participants in Africa/Stage 2 with solicited systemic events after the third study intervention administration. During 7 days after the third study intervention administration occurring at Day 169
Number of participants in Africa/Stage 2 with unsolicited adverse events (AEs) after the first study intervention administration. During 28 days after the first study intervention administration occurring at Day 1
Number of participants in Africa/Stage 2 with unsolicited adverse events (AEs) after the second study intervention administration. During 28 days after the second study intervention administration occurring at Day 57
Number of participants in Africa/Stage 2 with unsolicited adverse events (AEs) after the third study intervention administration. During 28 days after the third study intervention administration occurring at Day 169
Number of participants in Africa/Stage 2 with serious adverse events (SAEs). From first study intervention administration (Day 1) up to 28 days after the third study intervention administration (Day 197)
Number of participants in Africa/Stage 2 with AEs/SAEs leading to withdrawal from the study and/or withholding doses of study intervention. From first study intervention administration (Day 1) up to 28 days after the third study intervention (Day 197)
Number of participants in Africa/Stage 2 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 8
Number of participants in Africa/Stage 2 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 64
Number of participants in Africa/Stage 2 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 176
Number of participants in Africa/Stage 2 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 29
Number of participants in Africa/Stage 2 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 85
Number of participants in Africa/Stage 2 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 197

Order

Disease

iNTS

Version

NMA 2025

Phase

1/2a

Status

Recruiting